Factors That Determine the Responses to Meal Ingestion: Sex Differences
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Meal tolerance
Study Overview
Brief Summary
Aim: to determine the effect of gender on the responses to meal ingestion. Participants (10 men and 10 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (150 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •non-obese
Exclusion Criteria
- •history of gastrointestinal symptoms
- •prior obesity
- •use of medications
- •history of anosmia and ageusia
- •current dieting
- •alcohol abuse
- •psychological disorders
- •eating disorders
Arms & Interventions
Men
Intervention: probe meal (Other)
Women
Intervention: probe meal (Other)
Outcomes
Primary Outcomes
Meal tolerance
Time Frame: 100 min
Amount of meal (Kcal) consumed up to the level of maximal satiation (score 5 on a - 5 to + 5 score hunger/satiation scale).
Secondary Outcomes
- Change in digestive well-being induced by the probe meal(1 day)
- Change in fullness sensation induced by the probe meal(1 day)
- Change in mood induced by the probe meal(1 day)
- Change in abdominal discomfort induced by the probe meal(1 day)
- Change in hunger/satiety induced by the probe meal(1 day)